xTAG® Gastrointestinal Pathogen Panel (GPP) 1 sample, 1 test, 5 hours, 14 results

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Gastroenteritis—A Serious Medical and Economic BurdenA variety of bacterial, parasitic, and viral organisms may cause infectious gastroenteritis.• Diagnostically, it’s difficult to differentiate due to similar symptoms.1,2

• 80% of all cases of diarrhea are currently unidentified.2

Diarrhea inflicts a significant toll on the health care system and can result in a high degree of morbidity and mortality in select populations.3

• Globally, there are an estimated 2 billion cases of diarrheal disease every year, which kill approximately 1.8 million people annually.4

• In 2010, the U.S. associated cost for the 237,000+ patients suffering from gastrointestinal infections was over $6 billion.5

Hospital outbreaks of gastroenteritis may have undesirable consequences.5

• Outbreaks may lead to hospital ward closures or major disruption in routine hospital activity

Diarrhea can also have a major impact in society.• Significant number of days may be lost at school or work.

Inappropriate use of therapeutics provides favourable conditions for the emergence of resistant organ-isms.• When infections become resistant to first-line therapeutics, more expensive therapies must be used.• Prolonged and severe illness may lead to increased health care costs and financial burden.6

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Challenge

• Many causative agents of diarrheaare difficult to diagnose assymptoms are similar

• Traditional laboratory methods are notsensitive or specific enough, and not allsamples are tested for all diarrhea-causingpathogens, which can result in a lowdiagnostic yield (e.g. false negatives)

• Current methodologies and requestingpatterns mean that results take onaverage 2-3 days to be reported andin some cases more than 1 week• Prevention and control of outbreaks

Consequence

• Risk of delayed or wrongpatient treatment• Risk of improper and ineffectivetreatment with side effects, patientanxiety, inappropriate use of antibioticsand potential for antibiotic resistance

• Risk of delayed or wrongpatient treatment• Pressure on isolation facilitiesuntil results are available• Potential for outbreaks if patients withcommunicable infectiousgastroenteritis are not isolated

• Incorrect diagnosis impactingtreatment and bed isolationmanagement• Treatment side effects, antibioticresistance, patient anxiety• Prolonged needless isolation or lackof isolation with risk of outbreaks,(e.g. ward closures, damage toreputation and increased costs)

Solution

• xTAG GPP simultaneously detectsand identifies the bacterial, parasitic,and viral pathogens responsible forover 95% of cases of infectiousdiarrhea2

• Patient treatment can be optimizedmore quickly with improved outcomes

• xTAG GPP provides higher and betterdiagnostic yield for more appropriatepatient management• Optimized bed management helpscontrol costs and frees up beds forpatients that require isolation

• xTAG GPP has high negative andpositive predictive values forcorrect and reliable results*• Test takes only 5 hours forimmediate action9

GI Diagnostic Challenges and Clinical Consequences

The sensitivity and specificity data are described in the xTAG GPP package insert.

xTAG GPP : Transforming GI Diagnostics

1 Stool Sample, 1 Test, 14 Results—More results faster, enabling a higher diagnostic yield.

Benefits for physiciansxTAG GPP offers the ability to non-invasively analyze patient stool samples for 14 GI pathogen targets simultane-ously and at a much quicker processing time, as compared with conventional industry testing methods. A com-parison of existing techniques are summarized below:

Stool culture

Ova and parasite(O&P) exam

Rapid Tests(Rapid Immunoassays -lateral-flow,immunochromatography, dot blot)

Real-time PCR

ELISA

xTAG GPP

*Including extraction steps

Single bacterial pathogenper test

Parasitic pathogens

Single pathogen per test

1–3 pathogens per test

Single antigenantibody per test

Up to 14 bacterial, viral,and parasitic pathogens

in a single test

Up to 6%14

Up to 3%15, 16

Varies

Varies (depends on the pathogen target, individual performance and

number of assays)

30%

2–3 days

Several days - sample collectedover and up to 3 subsequent days

20–30 min

Under 5 hours ELISA Single antigen/antibody

per test 6 -24 hours

6 -24 hours

Under 5 hours*

Methods Tests for Turn-Around Time Percent Positive

xTAG GPP : PerformancexTAG GPP—Designed to Give You Confidence in Your Results

BACTERIAL/TOXIN (9)

Clostridium difficile Toxin A/B 99.76%

Shigella 99.78%

Campylobacter 99.32%

Salmonella 97.22%

Enterotoxigenic E.coli (ETEC) LT/ST 100%

Escherichia coli O157 99.75%

Shiga-like Toxin producing E.coli (STEC) stx1/stx2 100%

Yersinia enterocolitica 100%

Vibrio cholera 99.75%

PARASITIC (3)

Giardia lamblia 100%

Entamoebe histolytica 100%

Cryptosporidium 99.76%

VIRAL (3)

Rotavirus A 99.88%

Adenovirus 40/41 100%

Norovirus GI/GII 99.35%

Target (Pathogen) NPV*(Overall NPV = 99.41%)

* NPV is Negative Predictive Value. NPV data are derived from data generated with the Luminex® 100/200™ system. The data generated by the Luminex 100/200 and MAGPIX® systems are described in the xTAG GPP package insert. Data obtained with the MAGPIX system are expected to give comparable NPV values.

Intended UseThe xTAG GPP assay is indicated as an aid in the detection and identification of bacterial, parasitic and viral agents causing gastrointestinal infections in symptomatic (both acute and chronic gastroenteri-tis) adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected gastroenteritis. The xTAG GPP assay should be used in conjunction with other clinical and laboratory findings.18

A trained health care professional should carefully interpret the results from the xTAG GPP in conjunction with patients’ clini-cal signs, symptoms and results of other diagnostic tests.

Same Day Results for 14 of the Most CommonCauses of Infectious Diarrhea

Improve patient outcomes, avoid needless isolation costs, and act fast to prevent outbreak situations with xTAG® GPP—1 Stool Sample, 1 Test, 14 Results.From a single and simple laboratory test, you can get results for 14 of the most common causes of infectious gastroenteritis from a single stool sample in less than 5 hours. xTAG GPP is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis-causing viruses, bacteria and para-sites (including toxin gene detection) in human stool samples.

Test Overview

• Non-invasive stool test• Outstanding accuracy• Helps decrease and contain outbreaks of highly

contagious gastrointestinal infections• Turn-around time of just 24 hours!• Helps reduce over-prescription of antibiotics• Provide better patient care• Patients return specimens to th lab directly via FedEX• Widely covered by major insurances

This test is not recommended for in-patients hospitalized for more than 3 days.

Gastrointestinal Pathogen Panel (GPP), PCR Lab Ordering Code - GPP

Methodology:Performed:Reported:Specimen Required:

CPT Code(s):

Polymerase chain reaction (PCR)Varies24-48 hoursCollect : Small amount of fecal material - 2 g. or 2 mL liquid stool. Specimen preparation: Place into screw top Sterile Container. Storage/Transport Temperature: Refrigerated Stability: Refrigerated : 48 hours, Frozen : 2 month NOTE:* This test is not available for New York patients,please refer to test code V600 for specimen requirements.*

87507

4 bacterial, viral,

and parasitic pathogens

in a single test

1901 E Linden Avenue , Suite 4, Linden NJ 07036Phone: 908-474-1004 Fax: 908-474-0032

FOR MORE INFORMATION VISIT WWW.ACCUREFERENCE.COM

REFERENCE: 1. World Gastroenterology Organisation practice guide-line: Acute diarrhea, March 2008. World Gastroenterology Organisation (Internet). Cited 2014 September. Available from: http://www.worldgastroenterology.org/assets/down-loads/en/pdf/guidelines/01_acute_diarrhea.pdf.2. Scallan E., Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, Jones JL, and Griffin PM. Foodborne illness acquired in the United States—major pathogens. Emerg Infect Dis. 2011; 17:7-15.3. Bern et al. The magnitude of the global problem of diar-rheal disease: a ten-year Update Bulletin. World Health Organisation 1992;70:705–714.4. Diarrhoeal disease. World Health Organization (Inter-net). Cited 2014 September. Available from: http://www.who.int/mediacentre/factsheets/fs330/en/index.html.5. Chadwick PR et al. Journal of Hospital Infections (2000) 45:1-10.6. Antimicrobial Resistance. World Health Organization (Internet). Cited 2014 September. Available from: http://www.who.int/mediacentre/factsheets/fs194/en/.7. Lopman et al. Epidemiology and cost of nosocomial gastroenteritis, Avon, England, 2002-2003. Emerg Infect Dis. 2004;10(10):1827-34.8. Malecki et al. Rapid screening method for multiple gastroenteric pathogens also detects novel enterohemor-rhagic Escherichia coli O104:H4. Am J Infect Control. 2012 Feb;40(1):82-3.9. Claas et al. Performance of the xTAG® gastrointes-tinal pathogen panel, a multiplex molecular assay for simultaneous detection of bacterial, viral, and parasitic causes of infectious gastro enteritis. J Microbiol Biotechnol 2013;23(7):1041-1045.10. Malecki M. et al. Reviews in Medical Microbiology. 23(2):14-17, March 2012.11. Kahlau et al. Utility of two novel multiplexing assays for the detection of gastrointestinal pathogens – a first experience. SpringerPlus 2013;2:106.12. Hospital Healthcare Europe 2013 (www.hospitalhealth-care.com/hhe).13. Friesema IHM et al. Costs of gastroenteritis in the Netherlands, with special attention for severe cases. Eur J Clin Microbiol Infect Dis 2012;31:1895-1900.14. Slutsker L et al. Annals of Internal Medicine 1997; 126(7):505-513.15. Fotedar R et al. PCR Detection of Entamoeba histol-ytica, Entamoeba dispar, and Entamoeba moshkovskii in Stool Samples from Sydney, Australia. J Clin Microbiol. 2007;45(3):1035–1037.16. Tuncay S et al. The evaluation of the techniques used for diagnosis of Entamoeba histolytica in stool specimens. Turkiye Parazitoloji Dersigi 2007;31(3):188-193.17. Anson J. Gastroenteritis: A serious medical and economic burden—a new approach. Practical Patient Care UK, Issue 1 2012/13 (Internet). Cited 2014 September. Available from: http://www.luminexcorp.com/prod/groups/public/documents/lmnxcorp/gastroenteritis-burden.pdf.18. Luminex Corporation. xTAG Gastrointestinal Patho-gen Panel (GPP) Package Insert CE Marked